Label: DOMETUSS-G- guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochloride tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 1, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)Purpose
    Guaifenesin200 mgExpectorant
    Dextromethorphan HBr20 mgCough Suppressant
    Phenylephrine HCl10 mgNasal Decongestant
  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
    • temporarily reduces cough due to minor throat and bronchial irritation associated with a cold
    • calm the cough control center, and relieves coughing.
    • Temporarily relief nasal congestion due to the common cold
    • hay fever or other upper respiratory allergies
    • sinus congestion and pressure
  • Warnings

    • Do not exceed recommended dosage

    If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor.

    Do not use

    • if you are now taken a prescription Monoaminoxidase Inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions or Parkinson's disease), or for two weeks after stopping the MAOI drug; If you do not know if you are taking a prescription drug that contains an MAOI, ask a doctor or pharmacist before taking this product

    Do not take this product: for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor.

    Do not give this product if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

    Ask a doctor before use if you have

    • liver disease
    • if you are taking the blood thinning drug warfarin.

    Stop using this product and ask a doctor if

    • new symptoms occur
    • symptoms do not improve within 7 days or are accompanied by fever.
    • pain or fever persists or gets worse. These could be signs of a serious condition

    Keep out of reach of children.

    If you are pregnant or breast-feeding, ask a health professional before use.

  • Directions

    Do not take more than 6 doses in any 24 hours period.

    AgeDose
    adults and children 12 years of age and over1 tablets every 4 hours.
    children 6 to 12 years of age1/2 tablet every 4 hours.
    children under 6 years of ageConsult a doctor.
  • Other information

    • store at room temperature 15°- 30°C (59° - 86°F).

    Tamper evident

    Do not use if there is evidence of tampering.

  • Inactive ingredients

    Dicalcium phosphate, magnesium stearate, maltodextrin, mirocrystalline cellulose, povidone, silicon dioxide, stearic acid, talc.

  • Questions or comments?

    Calle de Diego #488
    San Juan P.R. 00924

    Phone: 787-767-3246
    For more information visit
    www.domelpharma.com

  • PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

    NDC 53809-250-01

    DOMETUSS-G

    DEXTROMETHORPHAN HBr/
    PHENYLEPHRINE HCl / GUAIFENESIN

    • Cough Suppressant
    • Nasal Decongestant
    • Expectorant

    100 TABLETS

    PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    DOMETUSS-G 
    guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53809-250
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code D2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53809-250-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/11/2019
    2NDC:53809-250-044 in 1 BOTTLE; Type 0: Not a Combination Product11/11/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/11/2019
    Labeler - DOMEL (808198837)
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